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Evaluation of the Effect of Human Recombinant Growth Hormone in Patients With Advanced Heart Failure

This study has been completed.
Study NCT00182169.   Last updated on September 12, 2005.   Information provided by McMaster University

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Descriptive Information Fields
Brief Title † Evaluation of the Effect of Human Recombinant Growth Hormone in Patients With Advanced Heart Failure
Official Title † Randomized, Placebo Control, Clinical Trial Evaluating the Effect of Human Recombinant Growth Hormone in Patients With Severe Congestive Heart Failure. The Growth Hormone In Heart Failure Trial (GIFT)
Brief Summary

Prospective randomized, placebo controlled, clinical trial to evaluate the effect of human growth hormone supplementation compared with placebo to patients with severe heart failure for a duration of 6 months on exercise capacity, heart function and quality of life
Detailed Description
Study Phase Phase II
Study Type † Interventional
Study Design † Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure † 6-minute walk test distance (functional capacity)measured at baseline, 3 months, and 6 months from the start of the study. Also measured at 3 months following discontinuation of therapy
Secondary Outcome Measure † Cardiac Function measured with radionuclide angiography and echocardiography
Exercise capacity measured during treadmill testing (duration of exercise)
Quality of life measured with Minnesota Living with Heart Failure
Neurohormones
baseline, 3 months, and 6 months from the start of the study. Also measured at 3 months following discontinuation of therapy
Condition † Heart Failure
Intervention † Drug: Human recombinant growth hormone
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status † Completed
Enrollment † 80
Start Date † July 1997
Completion Date June 2005
Eligibility Criteria †

Inclusion Criteria:

Individuals with a diagnosis of CHF, NYHA functional class III or IV symptoms, an EF of < 35 % estimated on radionuclide angiography (RNA) or 2D echo within the last 6 months, and a 6 minute walk distance of less than 400 meters. Patients must be stabilized on “CHF” therapy at the time of randomization.

Exclusion Criteria:

  1. Exercise limited by claudication, angina, neurological, pulmonary (FEV1 < 50%; FVC < 50%), or musculoskeletal disease.
  2. Active known malignancy; remission of < 5 years from the diagnosis of malignancy; patients with recurrence of malignancy are to be withdrawn from the study.
  3. Current diabetes with known retinopathy or patients with poorly controlled diabetes (ie. fasting glucose more than 13 mmol/l) or Type I diabetes mellitus.
  4. Any other non-cardiac condition that substantially decreases survival.
  5. Significant valvular stenosis or hypertrophic cardiomyopathy.
  6. Unable to comply with GH injection.
  7. Pregnancy or women of child bearing age not using adequate contraceptive means.
  8. Unstable angina, acute myocardial infarct, cardiac surgery, or PTCA within 3 months.
  9. Cor pulmonale.
  10. Acute myocarditis.
  11. Known need for cardiac surgery (e.g., valvular intervention, or CABG, or PTCA) within the next 6 months.
  12. Clinical hypothyroidism or hyperthyroidism with biochemical corroboration (TSH > 7 or < 0.2) at screening.
  13. Patients in need of urgent heart transplant within the next 6 months (patients on transplant list remain eligible).
  14. Sustained ventricular tachycardia (lasting > 30 seconds) on screening Holter.
  15. Significant liver disease (INR>1.4 off anticoagulant therapy; or AST, or ALT, or GGT, or alkaline phosphatase > 3X upper limit of normal; or bilirubin > 2X the upper limit of normal) at baseline.
  16. Failure to give informed consent
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries † Canada
Administrative Information Fields
NCT ID † NCT00182169
Organization ID 2004h00512
Secondary IDs ††
Study Sponsor † Hamilton Health Sciences
Collaborators ††
Investigators †
Study Director:     Catherine Demers, MD, MSc, FRCPC     McMaster University    
Information Provided By McMaster University
Verification Date March 2003
First Received Date † September 12, 2005
Last Updated Date September 12, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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